FDA UDI
In Commercial Distribution
🇺🇸 United States
Ankle Compression Nailing System
DI: 18033509858338
·
Model: 1
·
ORTHOFIX SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ankle Compression Nailing System
- Primary DI
- 18033509858338
- Version / Model
- 1
- Catalog Number
- 99-T770150
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 4
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 138de8d4-d1d1-419e-b173-f672ff84f904
Device Description
TITANIUM ANKLE COMPRESSION NAIL 10/150
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDS | Nail, Fixation, Bone | Orthopedic | 888.3030 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44854 | Arthrodesis nail, fixed-length | A rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18033509858338 | GS1 |
Customer Contacts
- Phone
- +039456719000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 10 | Millimeter | |
| Length | 150 | Millimeter |